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CIRCULAR No

CIRCULAR No. 08/2002/TT-BYT OF JUNE 20, 2002 GUIDING THE COOPERATION AND FOREIGN INVESTMENT IN THE FIELD OF MEDICAL EXAMINATION AND TREATMENT WITH TRADITIONAL MEDICINE IN VIETNAM

Pursuant to the Law on Protection of People�s Health; the Regulation on medical examination and treatment with traditional medicine and legal documents guiding the implementation of this Law;

Pursuant to the November 12, 1996 Law on Foreign Investment in Vietnam; the June 9, 2000 Law Amending and Supplementing a number of Articles of the Law on Foreign Investment in Vietnam and the legal documents guiding the implementation of the Law on Foreign Investment in Vietnam; the Government�s Decree No. 06/2000/ND-CP of March 6, 2000 on investment cooperation with foreign countries in the field of medical examination and treatment, education and training, scientific research;

Pursuant to the Enterprise Law and the legal documents guiding the implementation thereof; the Government�s Decree No. 11/1999/ND-CP of March 3, 1999 on goods banned from circulation, trade services banned from provision; goods and trade services subject to business restriction or conditional business;

Pursuant to the Ordinance on private medical and pharmaceutical practice; the Government�s Decree No.06/CP of January 29, 1994 detailing a number of articles of the Ordinance on private medical and pharmaceutical practice;

After obtaining the opinions of the Ministry of Planning and Investment in Official Dispatch No.3393/BKH-LDVX of May 30, 2002, the Health Ministry hereby guides the cooperation and foreign investment in the field of medical examination and treatment with traditional medicine in Vietnam as follows:

Chapter I

GENERAL PROVISIONS

Article 1.- Foreign organizations and individuals as well as overseas Vietnamese may invest in the field of medical examination and treatment with traditional medicine in Vietnam in the following forms of organization and investment:

1. Organizational forms:

1.1. Traditional medicine hospital.

1.2. Traditional medicine consultation and therapy clinics.

2. Investment forms:

2.1. 100% foreign capital.

2.2. Joint venture.

2.3. Business cooperation on the basis of business cooperation contracts.

Article 2.- Vietnamese organizations may cooperate with foreign countries in setting up foreign-invested establishments for medical examination and treatment with traditional medicine being:

1. Traditional medicine hospitals and traditional medicine consultation and therapy establishments which are non-business units with revenues of Vietnam.

2. Semi-public, people-founded and private traditional medicine hospitals, traditional medicine and pharmacy centers and traditional medicine consultation and therapy clinics, which are set up under the provisions of law.

3. Subjects prescribed in Article 2 of Decree No.24/2000/ND-CP of July 31, 2000 of the Government detailing the implementation of the Law on Foreign Investment in Vietnam.

Article 3.- Foreign-invested traditional medicine hospitals and traditional medicine consultation and therapy clinics (hereinafter referred collectively to as traditional medicine examination and treatment establishments) must satisfy all conditions prescribed in the Law on Foreign Investment in Vietnam, the Law on Protection of People�s Health, the Ordinance on Private Medical and Pharmaceutical Practice as well as other relevant law provisions, and observe the technically professional regulations issued by the Health Ministry.

Article 4.- The process of appraising projects and competence to grant investment licenses shall comply with the provisions in Clause 1, Article 109 and Clause 1, Article 114, of the Government�s Decree No.24/2000/ND-CP of July 31, 2000 detailing the Law on Foreign Investment in Vietnam.

Foreign-invested traditional medicine examination and treatment establishments, which have been granted investment licenses, may conduct professional activities only after they are granted certificates of eligibility for professional practice.

Article 5.- Foreign-invested traditional medicine examination and treatment establishments may operate only within the professional scope permitted by the Health Ministry. Charges for medical examination and treatment, for assorted tests, and prices of medicine must be reasonable and publicly posted up.

Article 6.- Foreign-invested traditional medicine examination and treatment establishments must re-fill in the procedures of application for new certificates of eligibility for professional practice in the following cases:

- Change in forms of investment or forms of organization.

- Separation or merger of establishment.

- Change of professional practice location.

- The expiry of certificate.

While their certificates of eligibility for professional practice are still valid, if wishing to replace the investors or directors, the establishments must report thereon to the Health Minister. The new directors must have proper professional practice certificates issued by the Health Ministry.

Article 7.- Foreign-invested traditional medicine examination and treatment establishments must pay appraisal charges, fees for the granting of certificates of eligibility for professional practice as provided for by law.

Chapter II

PROFESSIONAL PRACTICE CONDITIONS AND SCOPE OF FOREIGN-INVESTED TRADITIONAL MEDICINE EXAMINATION AND TREATMENT ESTABLISHMENTS

Article 8.- General conditions

1. The foreign-invested traditional medicine examination and treatment establishments must apply traditional medicine methods, combine traditional medicine with modern medicine in diagnosis and therapy with high efficiency and safety for patients.

2. They have modern equipment and facilities, which are being currently used in the world and suitable to each form of investment. Infrastructure and the contingent of medical staff must be up to the standards and compatible with the modern equipment and facilities and the scope of professional activities.

3. Foreign-invested traditional medicine examination and treatment establishments must be adequately supplied with electricity, water, sanitation works, fire-fighting equipment, ensure environmental hygiene and treat waste matters strictly according to regulations.

4. Directors of foreign-invested traditional medicine examination and treatment establishments must have certificates of practicing medical examination and treatment with traditional medicine, issued by the Health Ministry. The heads of the clinical departments, pre-clinical departments and pharmaceutical departments of the establishments must be physicians, pharmacists or galenic physicians or herbalists with appropriate specialties which they have practiced for full 5 years, and satisfy all other conditions prescribed by law. Doctors and medical personnel working at the establishments must also have appropriate specialties.

5. They have the contingent of personnel to ensure the operation requirements.

6. The tables of charges for medical examination and treatment, prices of medicine, charges for assorted tests must be reasonable and publicly posted up.

7. Foreigners who directly perform the medical examination and treatment must be tested by Vietnam�s Health Ministry for certification of their professional qualifications; if they cannot communicate in Vietnamese, the interpreters must have professional qualifications.

Article 9.- In addition to the general conditions prescribed in Article 8 of this Circular, the foreign-invested traditional medicine hospitals must satisfy all the following specific conditions:

1. Conditions:

1.1. The directors must have certificates of practicing medical examination and treatment with traditional medicine, issued by the Health Ministry of Vietnam.

1.2. The hospitals must have at least 20 beds each for in-patients.

1.3. Each hospital must be organized with at least the following departments and sections:

a) Consultation and out-patient department (including the emergency section).

Its foundation includes: The administrative section, the emergency room, the consultation room and the out-patient treatment room covering at least 20 square meters, arranged with two examination couches and two beds for out-patients.

The consultation rooms must be furnished adequately with tables and chairs, examination instruments, sphygmomanometers, thermometers. The emergency room must be furnished with oxygen syringes (with meters), first-aid medicine chest (with enough prescribed quantity of medicine), stretches, assorted splints, steaming cabinet and injection needles.

b) The in-patient area shall include the internal disease department, the surgery department, the gynaecological department, the paediatric department, the five- sense department, the acupuncture department.

- Each department must have at least: one administrative room, one operating room and in-patient rooms with the average standard of at least 4 square meters of floor per hospital bed, and the following equipment and furniture:

+ Adequate tables and chairs for medical workers, medical record cabinet.

+ Medicine distribution trolleys, scales.

- The in-patient departments must each have an emergency room, which must be equipped with first-aid medicine chest with adequate quantity of medicines as prescribed, sphygmomanometers, thermometers, oxygen syringes (or bags), stretches, pulse counters, drying cabinet, injection needles of all sorts.

The patients� rooms must be equipped with electric fans or air conditioners to keep the patients warm enough in winter and cool enough in summer. Each hospital bed must be supplied with a bedside cabinet and a thermos flask. Each patient must be supplied with at least two pairs of clothes for change.

Depending on their conditions, hospitals may have one or several in-patient departments.

c) The pharmaceutical department must have the administrative room, pharmaceuticals warehouses, preliminary processing area, medicine preparation area, the dispensary, ensuring the following requirements:

- The dispensary: The dispensary area must be airy, well ventilated and lit to avoid humidity and insects, equipped with tables for medical personnel and benches for patients, the compartment medicine cabinet, assorted scales, counters.

- The warehouses must be well ventilated against humidity and insects, and furnished with shelves and devices to contain medicines.

- The preliminary processing and preparation areas must be arranged separately, adequately supplied with clean water and furnished with drying and mixing tools, cutting knives, grinders, scales. Investment in modern machines is encouraged so as to raise the medical examination and treatment quality.

d) The pre-clinical department:

Depending on the conditions of each establishment, it must have at least an administrative room, a biochemical room, a micro-biological room, X-ray room, the electric cardiography room, ultrasonics room. Those rooms must be fully equipped with devices and instruments to ensure basic tests for patients.

e) The organizational, administrative and general planning section.

f) The finance and supplies section (including supplies warehouse).

The sections prescribed at Points e and f above must be arranged independently and meet the standards and conditions for operation and service of patients.

g) Intra-hospital communications must meet the movement demands of patients and hospital personnel and ensure convenience for transportation of emergency patients.

h) Hospitals must leave at least 40% of their land for the construction of yards and gardens. Housing space shall cover only 60% of their respective premises.

Article 10.- Scope of professional activities of traditional medicine hospitals: Based on the proposals of hospitals, the material and technical foundations and the professional qualifications of medical staff of the hospitals, the Health Ministry shall consider and permit the specific scope of professional activities.

Article 11.- In addition to the general conditions prescribed in Article 8 of this Circular, the foreign-invested traditional medicine consultation and therapy clinics must also satisfy the following specific conditions:

1. Their directors must have certificates of practicing medical examination and treatment with traditional medicine, issued by Vietnam�s Health Ministry.

2. Having investment licenses.

3. Their material and technical foundations:

3.1. Having at least two rooms satisfying the criteria and conditions of consultation rooms.

3.2. Having areas for preparation of traditional medicines in service of patients, with appropriate tools and equipment:

- Pharmaceutical warehouses must be airy and well ventilated to combat humidity and insects, equipped with shelves and cases to contain medicines.

- The preliminary processing and preparation areas: They must be arranged on separate areas, adequately supplied with clean water and furnished with kitchen as well as drying and mixing tools, cutting knives, grinders, scales.

- Dispensaries: The dispensary areas must be airy and well ventilated, well lit to avoid humidity and insects, furnished with tables for personnel and benches for patients, compartment medicine cabinets, assorted scales, counters.

3.3. Having waiting rooms for patients seeking consultation, with suitable conveniences.

3.4. Having pre-clinical section with adequate personnel as well as equipment and facilities as defined in the approved projects.

3.5. Having first-aid medicine chest and first-aid instruments as prescribed. Doctors and personnel of consultation and therapy clinics must be trained in first-aid techniques compatible with the permitted scope of professional activities.

Article 12.- Operating scope of traditional medicine consultation and therapy clinics.

1. Providing medical examination and treatment to out-patients by traditional medicine methods compatible with the permitted scope and the professional qualifications of the doctors of the consultation clinics.

2. Preparing raw pharmaceuticals into medicines, being entitled to sell finished products of traditional medicine which have been granted by the Health Ministry the registration numbers for production and circulation in service of patients. If preparing pre-packed traditional medicines of some sorts, they must register the formulas thereof and be permitted in writing by the Health Services of the provinces or centrally-run cities (hereinafter called collectively the provinces) where the consultation and therapy clinics are headquartered.

Chapter III

PROCEDURES AND COMPETENCE TO GRANT CERTIFICATES OF PROFESSIONAL PRACTICE AND ELIGIBILITY FOR PROFESSIONAL PRACTICE

Article 13.- Criteria for granting certificates of practicing medical examination and treatment with traditional medicine

1. Criteria for granting of certificates of practicing medical examination and treatment to foreigners:

- Having diplomas of traditional medicine physicians granted by medical universities or institutes. Having good professional knowledge appraised, examined and certified by the Health Ministry of Vietnam.

- Having professional practice certificates issued by competent agencies of their countries.

- Having practiced profession for at least 5 years at lawful traditional medicine establishments.

- Having professional ethics certified by the provincial Health Services of the localities where they are working.

- Having good health for practicing profession (with health certificates issued by provincial-level general hospitals).

- Having no criminal records, having not been disciplined for violation of professional regulations.

- Being knowledgeable about and committed to strictly comply with Vietnamese laws and professional regulations issued by Vietnam�s Health Ministry.

2. Criteria for the granting of traditional medicine and pharmacy practice certificates to Vietnamese: To comply with Circular No.04/2002/TT-BYT of May 29, 2002 of the Health Ministry guiding the consideration of granting medical and pharmaceutical practice certificates.

Article 14.- Dossiers of application for granting of certificates of medical examination and treatment with traditional medicine:

1. For foreigners:

a) The official dispatch of the Health Service of the province or centrally-run citiy where the foreigner applies for registration of professional practice.

b) The application for certificate of traditional medicine and pharmacy practice in Vietnam.

c) The curriculum vitae affixed with photo.

d) The judicial record.

e) The professional diploma.

f) The written certification of practice duration.

g) The foreign permit for professional practice.

h) The health certificate issued by the provincial/municipal general hospital.

i) The written commitment to comply with Vietnamese laws.

(All the above-prescribed papers must be translated into Vietnamese and notarized).

j) 3 photos of 3 x 4cm size.

2. For Vietnamese: The dossiers of application for certificate of practicing medical examination and treatment with traditional medicine by Vietnamese working in foreign-invested establishments shall comply with Circular No. 04/2002/TT-BYT of May 29, 2002 of the Health Ministry guiding the consideration of granting certificates of medical and pharmaceutical practice.

Article 15.- Dossiers of application for certification of professional qualifications of foreigners for working at traditional medicine examination and treatment establishments in Vietnam shall include:

1. The official dispatch of the Health Service of the province or centrally-run city where the foreigner applies to work.

2. The application for certification of professional qualifications.

3. The curriculum vitae affixed with photo.

4. The judicial record.

5. The professional diploma.

6. The written certification of practice duration.

7. The foreign permit for professional practice.

8. The health certificate issued by the hospital or medical center of the district or higher level.

9. The written commitment to strictly comply with Vietnamese laws.

(All the above-prescribed papers must be translated into Vietnamese and notarized).

10. The work permit issued by the provincial-level Service of Labor, War Invalids and Social Affairs.

11. The written certification of eligibility for professional practice by the traditional medicine examination and treatment establishment or the decision to set up the traditional medicine examination and treatment establishment, issued by competent body.

12. The provincial/municipal People�s Committee�s permit to employ foreign doctors by the establishment.

13. 3 photos of 4 cm x 6 cm size.

Article 16.- The dossiers of application for certification of professional qualifications to work in foreign-invested traditional medicine establishments shall comply with the provisions in Clauses 2, 3, 4, 5, 6, 7, 8, 9, 10 and 13 of Article 15 of this Circular.

Article 17.- Dossiers of application for certificates of eligibility for professional practice:

1. The official dispatch of the provincial/municipal Health Service, requesting the Health Ministry to make appraisal.

2. The investment license.

3. The investment project.

4. The enterprise charter.

5. The certification of the lawful use of land ground.

6. The ground plan.

7. The practicing certificate of the director.

8. The list of medical doctors and professional personnel with extracts of their curriculum vitae.

9. Other papers proving that the establishment satisfies the conditions prescribed in Articles 8, 9 and 11 of this Circular, depending on the investment forms.

Article 18.- The dossiers of application for practicing certificates and the dossiers of application for certification of professional qualifications for working in traditional medicine examination and treatment establishments of Vietnam, and the dossiers of application for certificates of eligibility for professional practice shall be addressed to the provincial/municipal Health Services which shall consider and send them to the Health Ministry.

The Health Minister shall grant certificates of eligibility for professional practices to foreign-invested traditional medicine examination and treatment establishments, the certificates of practicing medical examination and treatment with traditional medicine and the certificates of professional qualifications for working in traditional medicine examination and treatment establishments in Vietnam to foreigners.

Assisting the Health Minister is the Appraisal Council, the composition of which shall be decided by the Health Minister.

The Traditional Medicine Department shall act as the standing body of the Council.

Article 19.- The certificates of eligibility for professional practice, the certificates of professional practice and the certificates of professional qualifications prescribed in this Circular shall be valid for 5 years. Six months before the expiry thereof, the foreign-invested traditional medicine examination and treatment establishments, the grantees of professional practice certificates or certificates of professional qualifications must file their applications to the Health Ministry for consideration of extension thereof. Each extension shall not exceed 5 years.

Chapter IV

RIGHTS AND OBLIGATIONS OF FOREIGN-INVESTED TRADITIONAL MEDICINE EXAMINATION AND TREATMENT ESTABLISHMENTS, FOREIGN PRACTITIONERS IN VIETNAM

Article 20.- Apart from the rights and obligations prescribed in various laws, ordinances and the Government�s decrees, the foreign-invested traditional medicine examination and treatment establishments and foreigners practicing traditional medicine and pharmacy in Vietnam shall have the following rights and obligations:

1. Rights:

The traditional medicine examination and treatment establishments are entitled to organize drug stores to supply traditional medicines to in-patients and out-patients.

Medical personnel operating in foreign-invested traditional medicine examination and treatment establishments may join in study according to the State�s regulations on enrolment so as to raise their professional skills; participate in professional activities and fostering of the health service; and attend refresher courses organized by provincial/municipal Health Services or the Health Ministry to update their knowledge.

These traditional medicine examination and treatment establishments and individuals working therein, if recording many achievements in the cause of caring for and protecting people�s health, shall be commended according to general regulations of the Socialist Republic of Vietnam.

2. Obligations:

The directors of traditional medicine examination and treatment establishments must bear full responsibility before Vietnamese laws for the all activities of their establishments.

- To fulfill all tax and financial obligations as provided for by Vietnamese laws.

- To put up signboards as prescribed, to publicly post up the medical examination and treatment charges, prices of medicines and the approved professional practice scope. The foreign-invested traditional medicine examination and treatment establishments must draw up tables of hospital fees for report to the Health Ministry for approval.

- New medicines, new therapeutic methods must not be applied to examination and treatment for patients, if not yet so permitted by the Health Ministry.

- To be obliged to participate in epidemics prevention and combat, in national health programs.

- To fully comply with the professional regulations set by Vietnam�s Health Ministry, to implement the regime of occupational allowances and other provisions of Vietnamese laws like State-run medical units of Vietnam.

- All documents related to activities of the establishments must be written in or translated into Vietnamese.

Chapter V

STATE MANAGEMENT OF FOREIGN-INVESTED TRADITIONAL MEDICINE EXAMINATION AND TREATMENT ESTABLISHMENTS REGARDING PROFESSIONAL TECHNIQUES

Article 21.- The Health Ministry shall perform the function of State management regarding professional techniques of foreign-invested traditional medicine examination and treatment establishments throughout the country.

The provincial Health Services shall perform the function of State management regarding the professional techniques of foreign-invested traditional medicine examination and treatment establishments in their respective provinces.

Article 22.- The foreign-invested traditional medicine examination and treatment establishments must observe the regimes of making periodical reports and extraordinary reports upon request to the provincial Health Services and the Health Ministry.

Chapter VI

EXAMINATION, INSPECTION AND HANDLING OF VIOLATIONS

Article 23.- The Health Ministry and the provincial Health Services shall periodically organize examinations and inspections of the observance of professional regulations as well as law provisions on foreign-invested traditional medicine examination and treatment establishments.

Article 24.- The foreign-invested traditional medicine examination and treatment establishments are obliged to create conditions for and satisfy the requests of, examination and inspection delegations; and entitled to complain about decisions of the inspection delegations.

Article 25.- The foreign-invested traditional medicine examination and treatment establishments and foreign individuals practicing traditional medicine and pharmacy in Vietnam are obliged to fully comply with the provisions of this Circular and other relevant provisions of Vietnamese laws; if committing violations thereof, they shall be handled according to current regulations; if causing damage to patients, they must compensate therefor as provided for by Vietnamese laws.

Chapter VII

IMPLEMENTATION PROVISIONS

Article 26.- This Circular takes effect 15 days after its signing for promulgation. All previous regulations contrary to those of this Circular are hereby annulled.

Article 27.- The leading officials of the Departments, the Office, the Inspectorate and concerned units of the Ministry, the directors of provincial Health Services, the directors of foreign-invested traditional medicine examination and treatment establishments and foreigners practicing medical examination and treatment with traditional medicine in Vietnam shall have to implement this Circular.

If in the course of implementation any difficulties arise, the units and localities should report them to the Health Ministry (the Traditional Medicine Department) for guidance to settle them.

For the Health Minister

Vice Minister
LE VAN TRUYEN